Table 1. Summary of cancer risks in studies of recombinant human bone morphogenetic protein-2 (rh-BMP).*.
| Demographics | Mean | Risk, % (n/N) | ||||||
|---|---|---|---|---|---|---|---|---|
| Design | Surgery | Studies | Treatment | rhBMP | ICBG | follow-up, mo | rhBMP | Control |
| RCTs | PLF | Vaccaro et al5,6,7 | rhBMP-7 (7 mg) | Age, y: 63 % Male: 46 |
67 42 |
48 | 12.5 (3/24) | 8.3 (1/12) |
| PLF | FDA 3 (AMPLIFY™) Dimar et al8† | rhBMP-2 (40 mg) | Age, y: 53 % Male: 45 |
52 42 |
24 60 |
3.8 (9/239) 6.3 (15/239) |
0.9 (2/224) 2.2 (5/224) |
|
| PLF | Delawi et al4 | rhBMP-7 (OP-1) (3.5 mg/side) |
Age, y: 53 % Male: 56 |
55 38 |
12 | 5.6 (1/18) | 0 (0/16) | |
| ALIF | FDA 9‡ (InFUSE™) | rhBMP-2 (mg NR) |
Age, y: 43 % Male: 55 |
42 50 |
24 | 0.7 (1/143) | 0.7 (1/136) | |
| Cohort§ | Mixed∥ | Latzman et al10 | rhBMP-2 (12 mg/8 cc or 24 mg/16 cc) | Age, y: 50 % Male: 78 |
56 90 |
18 | 16.7 (4/24) | 7.6 (8/105) |
*
ICBG indicates iliac crest bone graft; PLF, posterolateral fusion; ALIF, anterior lumbar interbody fusions; and NR, not reported.
†
Dimar et al8 is the randomized control trial (RCT) for the FDA data summary. The authors report only eight cases of cancer in the rhBMP group, while the SSED reports nine at 24-month follow-up.
‡
Data from the pivotal RCT only. Results from the pilot RCT (N = 14) and the prospective case series (N = 134) submitted to FDA were not included in this analysis.
§
Retrospective chart review.
∥
Anterior approach, 9%; interbody cage placement, 44%.